Global Director, R&D QA

Job Summary

The Global Director, R&D QA is responsible for the overall leadership and execution of the quality assurance programs and policies across the R&D functions, including the development of R&D Policies and Systems.

Job Responsibilities

• Establish and maintain global policies and standards to support the compliance and business needs of the R&D organizations, consistent with the overall corporate Quality direction
• Quality oversight of all clinical and non-clinical trials conducted in support of submissions for Apotex Inc. and Apobiologix including the evaluation of CROs, Third Party Service Providers and Investigator sites

• Quality oversight and release of stability, submission and bio-batch manufacturing,  and testing in support of Apotex regulatory dossiers

• Quality oversight of the auditing of R&D documentation used in support of Apotex regulatory submissions

• Quality management of all 3rd party service providers utilized by the R&D organization to ensure the products meet all applicable regulatory and Apotex quality standards

• Oversight of compliance and quality management of the Global Pharmacovigilance processes and systems
• Proactively identify issues, concerns or any potential or significant risks to the business and if identified, ensure that there are appropriate preventative actions in place
• Actively participate as a member of the Apotex Quality Leadership team, providing input and direction in support of our Global Quality Program
• Champion of all office and corporate policies and procedures
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

All other duties as assigned.

Job Requirements

• Education
  • Sc. in Chemistry, Biochemistry or a related science
• Knowledge, Skills and Abilities
  • Thorough knowledge of GCP/GLP/GMP/GVP
  • Exhibited business acumen in understanding cross-functional processes, requirements, relevant information flows, and translating gaps into solutions
  • Demonstrated strategic, process-driven, analytical and critical thinking
  • Proficiency in communicating (both orally and in writing) concepts and information at all levels within an organization, particularly at the senior management level
  • Possession of strong interpersonal savvy and leadership skills as well as a collaborative management style
  • Proven experience in holding people accountable, developing cross-functional teams and facilitating decision-making processes; previous management experience preferred
  • Strong proficiency in all MS Office tools
  • Familiarity with existing corporate database technologies
  • Ability to handle various priorities in a fast-paced environment

• Experience

Minimum 10+ years experience in the pharmaceutical industry, 2 years of which has been spent in a laboratory environment and 3 – 5 years in a management role